Northstar Neuroscience is currently enrolling patients for two post-stroke clinical research studies. The first study is looking for stroke survivors with hand and/or arm weakness (hemiparesis) caused by their stroke. The second study is looking for stroke survivors who have difficulty speaking due to a post-stroke condition called Broca’s aphasia (also called expressive aphasia). More specific information about these studies can be found in the Stroke Motor Recovery and Aphasia sections.

See the Product and Therapy sections for more information about the components of the device and how it works.

Both clinical studies are designed to evaluate the safety and effectiveness of the Northstar Stroke Recovery System* together with stroke rehabilitation. The therapy involves the delivery of electrical stimulation to the part of the brain responsible for hand/arm or speech function. The stimulation is delivered only during the stroke rehabilitation sessions (not continuously) and is intended to reinforce and amplify recovery outcomes.

Over the past 15 years, this type of surface brain stimulation has been used with a low level of complications in several hundred patients neuropathic pain**. Moreover, patients have received the Northstar Stroke Recovery System in several previous studies with no unanticipated complications.

It is important to note that the Northstar Stroke Recovery System is considered investigational because the US Food and Drug Administration (FDA) has only approved it for use in Northstar's clinical studies. To learn more about participating in clinical trials, visit:
www.hhs.gov/ohrp/outreach or www.clinicaltrials.gov/ct/info/resources

* Caution: Investigational device. Limited by Federal (or U.S.) law to investigational use.

** Reference: T Tsubokawa et al. Acta Neurchir Suppl (Wien) 1991, Y Katayama et al. J. Neurosurg. 1998 and JP Nguyen et all, Pain 1999.

Eligible participants should carefully review all clinical study information and talk to their personal physician to make an informed choice about participating in a clinical trial.